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Compliance and Inspection Overview

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BRS has a comprehensive inspection system that uses science and risk criteria to

identify any potential noncompliance with APHIS biotechnology regulations. 

As part of the inspection process, BRS evaluates facilities, equipment, records, and

reports of potential noncompliance incidents. Authorizations under the permitting
procedures require that noncompliance incidents be self-reported within designated

time frames. 

If an incident occurs, our focus is to quickly restore compliance with regulatory

requirements to protect U.S. agriculture and prevent inadvertent commingling within

the food supply. Incidents with low potential impacts may require simple remedial

actions, such as correcting clerical errors, installing fencing, or improving monitoring

procedures. Serious incidents (such as unauthorized or accidental releases) can

require destruction of field test sites, quarantine of harvested crops, formal

corrective action plans, or other long-term measures. When self-reports occur,

authorization holders have typically already started to implement corrective actions.

BRS strives for long-term compliance by working to reassess and modify existing

procedures to prevent recurrence of incidents. 

BRS may refer a serious incident, or a history of incidents, to APHIS’ Investigative

and Enforcement Services (IES) for further investigation. BRS also works closely with

State/Territorial Departments of Agriculture and other government agencies,

including the Food and Drug Administration, the Environmental Protection Agency

and the Department of Justice, to ensure compliance with APHIS regulations. The 

Plant Protection Act authorizes broad sanctions for noncompliance, including civil

penalties up to $1.1 million. 

Reports and Notices

Persons authorized to engage in regulated activities must submit certain reports and

notices to BRS to communicate compliance-related information. Each report and/or

notice is associated with a permit or notification, and has specific requirements for

due dates and information. A report provides information on activities that already

happened, and a notice contains information on planned activities that will occur 

in the future. Reports and notices are used for initiating a BRS inspection process

or verifying the progress of field trials. 

Reports that persons submit to BRS in connection with regulated activities are

separate and apart from BRS-prepared inspection reports, which record observations

made independently by inspectors to document inspection findings and ensure

compliance with the regulations and permit conditions.  

Access to Reports and Notices User's Guide

Access to ePermits (XML) Instructions for Reports and Notices
Noncompliance History

Most persons authorized to engage in regulated activities have a successful history

of compliance with APHIS regulations.  From time-to-time, compliance incidents or

patterns of noncompliance occur.  When this occurs, BRS assesses the nature and

seriousness of the noncompliance and determines appropriate steps to follow up,

ranging from issuing regulatory correspondence to requesting an investigation and

seeking sanctions for alleged noncompliance.

View Noncompliance History

Compliance and the Site Inspection Process

BRS has a comprehensive inspection system that uses science and risk criteria to

identify any potential noncompliance. Inspection planning involves many factors,

including geographic location, time of year, species, the risk of crop persistence,

compliance history, and the type of authorization (permit or notification).

Learn More About the Compliance and Site Inspection Process

Report an Unauthorized/Accidental Release of a Regulated Article or Noncompliance Incident

As specified in regulations and permit conditions, persons engaging in regulated

activities must notify APHIS of any possible or actual unauthorized movements or

releases of the regulated material. This includes accidental releases or those caused

by flooding or other weather events. Time frames for reporting differ depending

upon the type of incident or observation and the conditions associated with the

authorization. It is important to carefully read the applicable regulations and

conditions associated with an authorization to ensure full compliance at all times.

Report an Unauthorized Release

Compliance Assistance

BRS provides compliance assistance to those involved in biotechnology research and

development, including small businesses and academic researchers, to facilitate

compliance with APHIS regulations (7 CFR part 340). Compliance assistance is

provided through a variety of mechanisms including learning opportunities, template
procedures, and the Biotechnology Quality Management Support (BQMS) Program.

Learn More About the Compliance Assistance Program